Palindrome Precision HSI Chronic Catheters Recalled for Antimicrobial Specification Failures
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or serious injury are typically scored as High (3), especially when the hazard involves a risk of harm (infection) that has not yet resulted in reported illness.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm (Item Code: 8888123409P) manufactured by Covidien LLC. The recall was initiated because the catheters may not meet antimicrobial specifications. The affected products are identified by item codes with an expiry date of February 2018 and earlier.
The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally. The products were distributed nationwide in the US and to numerous countries, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and the United Kingdom. The FDA classifies this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected catheters and contact their supplier or the manufacturer for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text, but the failure to meet antimicrobial specifications presents a potential risk of infection.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item codes identified with an expiry date of February 2018 and earlier
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 62 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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